Trial Outcomes & Findings for Cognitive Rehabilitation in Schizophrenia (NCT NCT00248794)

Results Overview

This is a measure of cognitive flexibility and the ability to shift set in the face of a changing reinforcement. The measure reflects "density" of perseverative errors in relation to the overall test performance. It is computed by calculating the ration of perseverative errors to trials administered and multiplied by 100. Then the percentage score is translate using the available Standard Score Tables provided in the manual and converted to a standard score with a mean of 100, a maximum of 145 and a minimum of 55, with higher Standard Scores indicating better performance.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

59 participants

Primary outcome timeframe

16 weeks after intake

Results posted on

2016-05-25

Participant Flow

Veterans with schizophrenia or schizoaffective disorder who met the following inclusion were recruited between 2004 and 2008.

Participant milestones

Participant milestones
Measure	CRT + Skills Training Cognitive Remediation therapy+ skills training Participants received up to 5 hours of CRT and weekly skills training group	ICBCR and Skills Training Individualized Computer Based Cognitive Remediation Participants received up to 5 hours of ICBRC and weekly skills group	Skills Group Control Participants received weekly skills group + up to five individual contacts with research staff without active cognitive training
Overall Study STARTED	25	24	10
Overall Study COMPLETED	19	16	7
Overall Study NOT COMPLETED	6	8	3

Reasons for withdrawal

Reasons for withdrawal
Measure	CRT + Skills Training Cognitive Remediation therapy+ skills training Participants received up to 5 hours of CRT and weekly skills training group	ICBCR and Skills Training Individualized Computer Based Cognitive Remediation Participants received up to 5 hours of ICBRC and weekly skills group	Skills Group Control Participants received weekly skills group + up to five individual contacts with research staff without active cognitive training
Overall Study Lost to Follow-up	6	8	3

Baseline Characteristics

Cognitive Rehabilitation in Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CRT +Skills Group n=25 Participants Participants receive upto 5 hours of CRT and weekly skills training group for 15 weeks	ICBCR + Skills Group n=24 Participants Participants receive upto 5 hours of ICBCR and weekly skills training group for 15 weeks	Skills Group Only n=10 Participants Participants receive upto 5 hours of generic staff contact and weekly skills training group for 15 weeks	Total n=59 Participants Total of all reporting groups
Age, Continuous	49.4 years STANDARD_DEVIATION 6.7 • n=5 Participants	47.6 years STANDARD_DEVIATION 8.1 • n=7 Participants	48.1 years STANDARD_DEVIATION 6.9 • n=5 Participants	47.8 years STANDARD_DEVIATION 7.2 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	20 Participants n=7 Participants	9 Participants n=5 Participants	50 Participants n=4 Participants
Region of Enrollment United States	25 participants n=5 Participants	24 participants n=7 Participants	10 participants n=5 Participants	59 participants n=4 Participants

PRIMARY outcome

Timeframe: 16 weeks after intake

This is a measure of cognitive flexibility and the ability to shift set in the face of a changing reinforcement. The measure reflects "density" of perseverative errors in relation to the overall test performance. It is computed by calculating the ration of perseverative errors to trials administered and multiplied by 100. Then the percentage score is translate using the available Standard Score Tables provided in the manual and converted to a standard score with a mean of 100, a maximum of 145 and a minimum of 55, with higher Standard Scores indicating better performance.

Outcome measures

Outcome measures
Measure	CRT + Skills Training n=25 Participants Cognitive Remediation therapy-Up to 5 hours of one on one cognitive remediation using CRT. All subjects randomized to this condition also are receiving the weekly skills group. Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities	ICBCR and Skills Training n=24 Participants Individualized Computer Based Cognitive Remediation-Up to 5 hours of of computer based cognitive remediation (ICBCR). All subjects randomized to this condition also are receiving the weekly skills group. Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities	Skills Group Control n=10 Participants Life skills group + up to five individual contacts with research staff without active cognitive training
Wisconsin Card Sort Percent Perseverative Errors (Standard Score)	87.54 standard score units Standard Deviation 4.04	87.88 standard score units Standard Deviation 3.98	91.80 standard score units Standard Deviation 6.30

PRIMARY outcome

Timeframe: 16 weeks from intake

Population: Two way ANOVA using baseline and completion of intervention data

21 Item audio-visual task that measures the ability to recognize affective states in others. Affective states presented include: Happiness, Sadness, Surprise, Disgust, Fear, Anger and No Emotion. The instrument is scored for total correct responses with scores ranging from 0 to 21 with higher scores indicate better overall performance.

Outcome measures

Outcome measures
Measure	CRT + Skills Training n=25 Participants Cognitive Remediation therapy-Up to 5 hours of one on one cognitive remediation using CRT. All subjects randomized to this condition also are receiving the weekly skills group. Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities	ICBCR and Skills Training n=24 Participants Individualized Computer Based Cognitive Remediation-Up to 5 hours of of computer based cognitive remediation (ICBCR). All subjects randomized to this condition also are receiving the weekly skills group. Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities	Skills Group Control n=10 Participants Life skills group + up to five individual contacts with research staff without active cognitive training
Bell Lysaker Emotion Recognition Test	14.17 total correct Standard Deviation .74	13.40 total correct Standard Deviation .73	14.50 total correct Standard Deviation 1.15

PRIMARY outcome

Timeframe: 16 weeks after intake assessment

CPT relative X/A Percentage. This is a task-oriented computerized assessment of attention-related problems. This variable measures the relative sustained attention, and vigilance over the time of the task. Raw performance is standardize using available age and education norms yielding a Standardized Score with a mean of 100. Maximum Standard score is 145 and the minimum is 55 with higher scores reflect better performance.

Outcome measures

Outcome measures
Measure	CRT + Skills Training n=24 Participants Cognitive Remediation therapy-Up to 5 hours of one on one cognitive remediation using CRT. All subjects randomized to this condition also are receiving the weekly skills group. Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities	ICBCR and Skills Training n=25 Participants Individualized Computer Based Cognitive Remediation-Up to 5 hours of of computer based cognitive remediation (ICBCR). All subjects randomized to this condition also are receiving the weekly skills group. Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities	Skills Group Control n=10 Participants Life skills group + up to five individual contacts with research staff without active cognitive training
Continuous Performance Task X/A Version	91.31 units on a scale (standardized units) Standard Deviation 3.55	92.65 units on a scale (standardized units) Standard Deviation 3.48	92.17 units on a scale (standardized units) Standard Deviation 5.50

PRIMARY outcome

Timeframe: 16 weeks post intake assessment

This is measure of verbal learning and memory for immediate recall. Respondents are read a list of 12 items and asked to repeat once the last item is given. The list if given 3 times. Each time all items are recorded giving a total score ranging from 0 to 36. The score is converted to T-scores (mean of 50 and sd of 10) using the norms in the manual. The data reported are that in T-Scores with higher scores indicating better functioning.

Outcome measures

Outcome measures
Measure	CRT + Skills Training n=24 Participants Cognitive Remediation therapy-Up to 5 hours of one on one cognitive remediation using CRT. All subjects randomized to this condition also are receiving the weekly skills group. Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities	ICBCR and Skills Training n=25 Participants Individualized Computer Based Cognitive Remediation-Up to 5 hours of of computer based cognitive remediation (ICBCR). All subjects randomized to this condition also are receiving the weekly skills group. Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities	Skills Group Control n=10 Participants Life skills group + up to five individual contacts with research staff without active cognitive training
Hopkins Verbal Learning Test- Total Recall Variable	36.33 units on a scale (T-scores) Standard Deviation 2.19	32.56 units on a scale (T-scores) Standard Deviation 2.14	32.90 units on a scale (T-scores) Standard Deviation 3.39

PRIMARY outcome

Timeframe: 16 weeks after intake

Independent Living Skills Survey is a 103 items that assess 12 areas of skills; personal hygiene (6 items), appearance and care of clothing (12 items), care of personal possessions and living space (9 items), food preparation (9 items), care of one's own health and safety (10 items), money management (10 items), transportation (7 items), leisure and recreational activities (13 items), job seeking (6 items), job maintenance (3 items), eating behaviors (9 items), and social interactions (9 items). The items describe relatively specific skills such as "washes hair twice a week," and informants indicate how frequently an individual has performed each skill within the past month. The responses are yes (1 point) no (0 points). Scores reports are the average #of yes items/number of total items. Higher scores indicating better functioning.

Outcome measures

Outcome measures
Measure	CRT + Skills Training n=24 Participants Cognitive Remediation therapy-Up to 5 hours of one on one cognitive remediation using CRT. All subjects randomized to this condition also are receiving the weekly skills group. Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities	ICBCR and Skills Training n=25 Participants Individualized Computer Based Cognitive Remediation-Up to 5 hours of of computer based cognitive remediation (ICBCR). All subjects randomized to this condition also are receiving the weekly skills group. Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities	Skills Group Control n=10 Participants Life skills group + up to five individual contacts with research staff without active cognitive training
Independent Living Skills Survey	.73 units on a scale Standard Error .02	.73 units on a scale Standard Error .02	.77 units on a scale Standard Error .04

Adverse Events

CRT+Skills Group

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

ICBCR + Skills Group

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Skills Group + Generic Contact

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CRT+Skills Group n=25 participants at risk Cognitive Remediation therapy-Up to 5 hours of one on one cognitive remediation using CRT. All subjects randomized to this condition also are receiving the weekly skills group. Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities	ICBCR + Skills Group n=24 participants at risk Individualized Computer Based Cognitive Remediation-Up to 5 hours of of computer based cognitive remediation (ICBCR). All subjects randomized to this condition also are receiving the weekly skills group. Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities	Skills Group + Generic Contact n=10 participants at risk Life skills group + up to five individual contacts with research staff without active cognitive training
Psychiatric disorders increase in psychiatric symptoms	4.0% 1/25 • Number of events 1 • 2004-2008	4.2% 1/24 • Number of events 1 • 2004-2008	10.0% 1/10 • Number of events 1 • 2004-2008
Cardiac disorders Cardiac event	4.0% 1/25 • Number of events 1 • 2004-2008	0.00% 0/24 • 2004-2008	0.00% 0/10 • 2004-2008

Other adverse events

Other adverse events
Measure	CRT+Skills Group n=25 participants at risk Cognitive Remediation therapy-Up to 5 hours of one on one cognitive remediation using CRT. All subjects randomized to this condition also are receiving the weekly skills group. Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities	ICBCR + Skills Group n=24 participants at risk Individualized Computer Based Cognitive Remediation-Up to 5 hours of of computer based cognitive remediation (ICBCR). All subjects randomized to this condition also are receiving the weekly skills group. Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities	Skills Group + Generic Contact n=10 participants at risk Life skills group + up to five individual contacts with research staff without active cognitive training
General disorders sought non psychiatric medical attention in ER	16.0% 4/25 • Number of events 7 • 2004-2008	20.8% 5/24 • Number of events 9 • 2004-2008	20.0% 2/10 • Number of events 4 • 2004-2008
Psychiatric disorders Went to Psych ER but was not hospitalized	8.0% 2/25 • Number of events 4 • 2004-2008	8.3% 2/24 • Number of events 5 • 2004-2008	10.0% 1/10 • Number of events 2 • 2004-2008

Additional Information

Gary Bryson

VA Connecticut Healthcare System

Phone: 860-594-6348

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place